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FDA Update 2011 presented FDA Update 2011 presented

by Bennett Napier, CAEby Bennett Napier, CAE

FDA Enforcement Statistics Summary 2010FDA Enforcement Statistics Summary 2010 Type of EnforcementType of Enforcement SeizuresSeizures InjunctionsInjunctions ConvictionsConvictions Warning LettersWarning Letters RecallsRecalls

Number of InstancesNumber of Instances 88 55 369369 445445 2,7212,721

FDA Enforcement Statistics Summary 2010FDA Enforcement Statistics Summary 2010 Type of EnforcementType of Enforcement 483 Letters Issued483 Letters Issued InspectionsInspections Import RefusalsImport Refusals FinesFines

Number of InstancesNumber of Instances 4,9874,987 15,24515,245 17,90717,907 $846,591,080$846,591,080

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Top Ten Warning Letter Cites for Medical Top Ten Warning Letter Cites for Medical Devices including dental- 2010Devices including dental- 2010

21 CFR 820.2221 CFR 820.22 41 Quality Audit41 Quality Audit 21 CFR 820.30(g)21 CFR 820.30(g) 28 Design Controls28 Design Controls 21 CFR 820.198(a)21 CFR 820.198(a) 28 Complaint File28 Complaint File 21 CFR 820.75(a)21 CFR 820.75(a) 27 Process Validation27 Process Validation 21 CFR 820.100(a)21 CFR 820.100(a) 25 CAPA25 CAPA

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Top Ten Warning Letter Cites for Medical Top Ten Warning Letter Cites for Medical Devices including dental- 2010Devices including dental- 2010

21 CFR 820.30(i)21 CFR 820.30(i) 21 Design Controls21 Design Controls 21 CFR 820.18421 CFR 820.184 21 Device Record21 Device Record 21 CFR 820.30(a)21 CFR 820.30(a) 20 Design Controls20 Design Controls 21 CFR 820.80(d)21 CFR 820.80(d) 19 Receiving 19 Receiving 21 CFR 820.198(c)21 CFR 820.198(c) 19 Complaint File19 Complaint File

Sixteen Device Specialty CategoriesSixteen Device Specialty Categories21 CFR (part 800-1299)21 CFR (part 800-1299)

872872 Dental Dental 874874 Ear, nose and throat Ear, nose and throat 876876 Gastroenterology & Gastroenterology &

urology devicesurology devices

878878 General and plastic General and plastic surgerysurgery

880880 General hospital and General hospital and personal usepersonal use

882882 Neurological Neurological

Medical Device Definition in Sec 201(h) of the FD&C Act

Medical Device ReportingMedical Device Reporting Another key regulatory development is an announcement by the FDA in August 2009 Another key regulatory development is an announcement by the FDA in August 2009

that beginning February 2011 medical device manufacturers, importers and facilities that beginning February 2011 medical device manufacturers, importers and facilities will be required to submit Adverse Event Reports (AERs) to CDRH electronically. will be required to submit Adverse Event Reports (AERs) to CDRH electronically.

Currently, CDRH receives most incident reports on paper which then needs to be Currently, CDRH receives most incident reports on paper which then needs to be input into the Manufacturer and User Facility Device Experience (MAUDE) database. input into the Manufacturer and User Facility Device Experience (MAUDE) database.

The FDA says the existing process is not only costly, but hinders CDRH’s ability to The FDA says the existing process is not only costly, but hinders CDRH’s ability to review safety data quickly to uncover potential public health problems. USFDA has review safety data quickly to uncover potential public health problems. USFDA has posted information about this new initiative to its website.posted information about this new initiative to its website.

Medical Device Reporting (MDR)Medical Device Reporting (MDR)“Adverse Event Reporting”“Adverse Event Reporting”

(21 CFR Part 803)(21 CFR Part 803) Mechanism for FDA to identify and monitor significant adverse events involving Mechanism for FDA to identify and monitor significant adverse events involving

medical devices. New requirements is that reporting is all done online now at fda.gov medical devices. New requirements is that reporting is all done online now at fda.gov no more paper submissionsno more paper submissions

Events: Death, Serious Injury and Malfunction

Reported by: Manufacturer, User Facility, and Importers of medical devices

References of Note for 2011References of Note for 2011 2011 FDA Budget Request (dental laboratories mentioned by name) 2011 FDA Budget Request (dental laboratories mentioned by name)

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetRepohttp://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM202323.pdfrts/UCM202323.pdf

Unique Device Identifier Program Excerpt - “UDI impact on dental laboratories and Unique Device Identifier Program Excerpt - “UDI impact on dental laboratories and other custom devices are not yet clear to some in industry. Labs making custom other custom devices are not yet clear to some in industry. Labs making custom products under DDS direction are not registered as manufacturers. Some DDS still products under DDS direction are not registered as manufacturers. Some DDS still have their own lab in the practice.” have their own lab in the practice.”

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Uniquehttp://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers/UCM235964.pdfDeviceIdentifiers/UCM235964.pdf UDI reference to dental laboratories UDI reference to dental laboratories

Import Posture for FDAImport Posture for FDA Fiscal Year 2010 – 20 million shipments of FDA regulated imports Fiscal Year 2010 – 20 million shipments of FDA regulated imports

U.S. Government Accountability Office report to Congress in 2010 U.S. Government Accountability Office report to Congress in 2010 indicated only 8% of shipments are being inspectedindicated only 8% of shipments are being inspected

Budget request for additional $70 million in funding to increase at Budget request for additional $70 million in funding to increase at port inspections of imported productsport inspections of imported products

Dental Laboratory Data for Import Restorations 2010Dental Laboratory Data for Import Restorations 2010 (NAICS) codes comprise the medical devices industry that is covered by the Office of (NAICS) codes comprise the medical devices industry that is covered by the Office of

Health and Consumer Goods (OHCG) Based on FDA 2010 data, total medical device Health and Consumer Goods (OHCG) Based on FDA 2010 data, total medical device imports for the U.S. was $33 billionimports for the U.S. was $33 billion

According to the FDA data, Dental laboratories (NAIC 339116; account for about According to the FDA data, Dental laboratories (NAIC 339116; account for about 4 4 percentpercent of import total measured by value of shipment (VOS) include crowns, of import total measured by value of shipment (VOS) include crowns, dentures, bridges and other orthodontic products. dentures, bridges and other orthodontic products.

4 percent equals $1.32 billion. If you use IDATA Research as measure which 4 percent equals $1.32 billion. If you use IDATA Research as measure which speculates $10.7 billion in sales, % is 12%. If you use NADL/ADA data on U.S. lab speculates $10.7 billion in sales, % is 12%. If you use NADL/ADA data on U.S. lab sales, percentage is 20%. Again this is percentage of sales not units. If you use units sales, percentage is 20%. Again this is percentage of sales not units. If you use units as the measure based on average offshore price point, its likely to be 35% of units.as the measure based on average offshore price point, its likely to be 35% of units.

FDA Automated SystemFDA Automated SystemOASIS SystemOASIS System (Operational and (Operational andAdministrative System for Import Support)Administrative System for Import Support)

OASIS is an automated FDA system for processing and making OASIS is an automated FDA system for processing and making admissibility determinations for shipments of foreign-origin, admissibility determinations for shipments of foreign-origin, FDA-regulated products seeking to enter U.S. commerce.FDA-regulated products seeking to enter U.S. commerce.

PREDICT SystemPREDICT System FDA's new PREDICT risk-based screening system for imports is coming FDA's new PREDICT risk-based screening system for imports is coming

soon. soon. It will replace the admissibility screening function of OASIS, FDA's legacy It will replace the admissibility screening function of OASIS, FDA's legacy

system. system. PREDICT will assist entry reviewers in targeting higher-risk shipments for PREDICT will assist entry reviewers in targeting higher-risk shipments for

examination. examination. It will also expedite the clearance of lower-risk cargo, but only if accurate It will also expedite the clearance of lower-risk cargo, but only if accurate

and complete data are provided by importers and entry filers.and complete data are provided by importers and entry filers.

Labeling ReminderLabeling Reminder Sec. 801.1 Medical devices; name and place of business of manufacturer, Sec. 801.1 Medical devices; name and place of business of manufacturer,

packer or distributor. packer or distributor.

(a) The label of a device in package form shall specify conspicuously the name and place (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.of business of the manufacturer, packer, or distributor.

(b) The requirement for declaration of the name of the manufacturer, packer, or (b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.the name under which the business is conducted shall be used.

Labeling ReminderLabeling Reminder Sec. 801.1 Medical devices; name and place of business of Sec. 801.1 Medical devices; name and place of business of

manufacturer, packer or distributor. manufacturer, packer or distributor.

(c) (c) Where a device is not manufactured by the person whose Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the factsany other wording that expresses the facts

Labeling Reminder - continuedLabeling Reminder - continued .(d) The statement of the place of business shall include the .(d) The statement of the place of business shall include the street address, city, State, street address, city, State,

and Zip Code; however, the street address may be omitted if it is shown in a and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directorycurrent city directory or telephone directory. The requirement for inclusion of the ZIP . The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).appear on either the label or the labeling (including the invoice).

(e) (e) If a person manufactures, packs, or distributes a device at a place other than If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or business in lieu of the actual place where such device was manufactured or packed or is to be distributedpacked or is to be distributed, unless such statement would be misleading., unless such statement would be misleading.

Office of Regulatory Office of Regulatory Affairs (ORA)Affairs (ORA)

ORA is the lead office for all ORA is the lead office for all FDA field activities as well as FDA field activities as well as providing FDA leadership on providing FDA leadership on importsimports,, inspections, and inspections, and enforcement policy.  enforcement policy.  

Inspection PreparationInspection Preparation

Preparing Ahead For anPreparing Ahead For anFDA InspectionFDA Inspection

General TipsGeneral Tips• The time to start The time to start preparingpreparing for an FDA inspection is before they call. for an FDA inspection is before they call.• Keep all records and documents current and appropriately filed (easily Keep all records and documents current and appropriately filed (easily

accessible)accessible)• Keep all communications from different studies separate from each otherKeep all communications from different studies separate from each other

Preparing Ahead For an FDA InspectionPreparing Ahead For an FDA Inspection

Document and file all pertinent communication with key Document and file all pertinent communication with key sponsor personnel and with other external personnel sponsor personnel and with other external personnel (vendors, project partners, etc.)(vendors, project partners, etc.)

Conduct periodic QC reviews to ensure data integrity Conduct periodic QC reviews to ensure data integrity Identify/know team/personnel who will interact/respond to Identify/know team/personnel who will interact/respond to

FDA during an inspectionFDA during an inspection

Preparing Ahead For an FDA InspectionPreparing Ahead For an FDA Inspection

Ensure all staff are educated on proper conduct Ensure all staff are educated on proper conduct during an FDA inspectionduring an FDA inspection

Know GCPs, regulations/guidelines, SOPs and Know GCPs, regulations/guidelines, SOPs and study specific information (or at least know how to study specific information (or at least know how to access resources to get the information)access resources to get the information)

FDA Inspection OutcomesFDA Inspection Outcomes No inspectional findingsNo inspectional findings FDA 483 ObservationsFDA 483 Observations

• Documents non-compliance with regulations only (can not cite for non-Documents non-compliance with regulations only (can not cite for non-compliance with guidelines)compliance with guidelines)

• May be left at the site at the end of the inspection or sent laterMay be left at the site at the end of the inspection or sent later• EIR (Establishment Inspection Report) EIR (Establishment Inspection Report) • Will list findings: non-compliance with both regulations and guidelinesWill list findings: non-compliance with both regulations and guidelines• Site/Organization may or may not receive a copySite/Organization may or may not receive a copy

Compliance ClassificationsCompliance Classifications NAI – NAI – No Action IndicatedNo Action Indicated

Inspected firm is in complianceInspected firm is in compliance VAI - VAI - Voluntary Action IndicatedVoluntary Action Indicated

Deviation(s) from the regulationsDeviation(s) from the regulations

Voluntary correction is requestedVoluntary correction is requested OAI - OAI - Official Action IndicatedOfficial Action Indicated

Because of serious non-compliance requiring regulatory or administrative action by FDABecause of serious non-compliance requiring regulatory or administrative action by FDA

Adequate FDA 483 ResponseAdequate FDA 483 Response Submit a prompt written responseSubmit a prompt written response

-assess the root cause of the problem-assess the root cause of the problem

-Explain actions to correct the problem-Explain actions to correct the problem

-Evaluate the extent of the problem-Evaluate the extent of the problem

-Implement preventative actions to avoid recurrence-Implement preventative actions to avoid recurrence

-include supporting documentation-include supporting documentation

-provide REALISTIC timelines for implementation and correction-provide REALISTIC timelines for implementation and correction

Q&A with FDAQ&A with FDA QuestionQuestion: If a foreign dental laboratory is "partially finishing" dental restorations : If a foreign dental laboratory is "partially finishing" dental restorations

and shipping them to domestic dental laboratories as a component and not a and shipping them to domestic dental laboratories as a component and not a finished case does that trigger the domestic lab to register as an Initial Importer?finished case does that trigger the domestic lab to register as an Initial Importer?

   AnswerAnswer: The domestic lab would not necessarily have to register as an initial : The domestic lab would not necessarily have to register as an initial

importer of a component, however, they should be registering as repackager / importer of a component, however, they should be registering as repackager / relabeler if they are taking a finished device that they imported and changing relabeler if they are taking a finished device that they imported and changing the original labeling and packaging from that being provided by the foreign the original labeling and packaging from that being provided by the foreign dental laboratory. The imported case must comply with the applicable 801 dental laboratory. The imported case must comply with the applicable 801 labeling regulations.labeling regulations.

Q & A with FDAQ & A with FDA QuestionQuestion: What are special requirements for dental laboratories that make sleep : What are special requirements for dental laboratories that make sleep

apnea/snoring devices“? Dentists prescribe the device and the dental laboratory makes the apnea/snoring devices“? Dentists prescribe the device and the dental laboratory makes the device. device.

AnswerAnswer: Due to the classification of such devices, a dental laboratory may have to register as : Due to the classification of such devices, a dental laboratory may have to register as a contract manufacturer. If a dental laboratory manufactures a sleep apnea/snoring device a contract manufacturer. If a dental laboratory manufactures a sleep apnea/snoring device then they have to follow the guidance given by ODE regarding when they are a manufacturer.  then they have to follow the guidance given by ODE regarding when they are a manufacturer.  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072728.htm72728.htm       

If a dental laboratory advertises to dentists that they can make a snoring appliance of their If a dental laboratory advertises to dentists that they can make a snoring appliance of their own design, then the dental laboratory is operating as a manufacturer of a finished device and own design, then the dental laboratory is operating as a manufacturer of a finished device and no longer solely operating as a dental laboratory.  no longer solely operating as a dental laboratory.  

Q & A with FDAQ & A with FDA QuestionQuestion: As it relates to point of origin labeling, our understanding from previous FDA responses is, : As it relates to point of origin labeling, our understanding from previous FDA responses is,

that a dental laboratory that outsources domestically or to a foreign dental laboratory has to disclose that a dental laboratory that outsources domestically or to a foreign dental laboratory has to disclose such in labeling to the dentist, by providing company name, physical address of the third party such in labeling to the dentist, by providing company name, physical address of the third party provider, whether, the restoration was outsourced in full or part? Is that the correct interpretation? provider, whether, the restoration was outsourced in full or part? Is that the correct interpretation? 

   AnswerAnswer: When a dental device is manufactured by a foreign dental laboratory it must be labeled in : When a dental device is manufactured by a foreign dental laboratory it must be labeled in

compliance with the requirements of 21 CFR 801.1 Medical devices; name and place of business of compliance with the requirements of 21 CFR 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. If the importer (domestic dental laboratory) decides to repackage manufacturer, packer or distributor. If the importer (domestic dental laboratory) decides to repackage and relabel the dental device, then the labeling must also comply with 801.1. There are no FDA and relabel the dental device, then the labeling must also comply with 801.1. There are no FDA regulations requiring the disclosure of what percentage of a device was outsourced for regulations requiring the disclosure of what percentage of a device was outsourced for manufacturing, or the country of origin of a device. Country of origin requirements come from U.S. manufacturing, or the country of origin of a device. Country of origin requirements come from U.S. Customs and Border Protection. Customs and Border Protection. 

. . 

Q &A With FDAQ &A With FDA

QuestionQuestion: If an individual dental laboratory in one physical location is : If an individual dental laboratory in one physical location is manufacturing sleep apnea devices does each location need to manufacturing sleep apnea devices does each location need to register if it is a branch location of a conglomerate? register if it is a branch location of a conglomerate? 

   AnswerAnswer:  Each individual dental laboratory that is manufacturing a :  Each individual dental laboratory that is manufacturing a

sleep apnea device needs to register each individual facility, even sleep apnea device needs to register each individual facility, even though they are a branch location of a conglomerate.though they are a branch location of a conglomerate.

  

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Industry Assistance CDRH ResourcesIndustry Assistance CDRH Resources CDRH Learn CDRH Learn [New][New]

• Modules include various premarket and post-market informationModules include various premarket and post-market information• Available 24/7Available 24/7• Certificate generated per topic upon passing post-testsCertificate generated per topic upon passing post-tests• Suggest Future topicsSuggest Future topics• http://www.fda.gov/cdrh/cdrhlearn/http://www.fda.gov/cdrh/cdrhlearn/

Device AdviceDevice Advice• Self-service website Self-service website • Searchable by topicSearchable by topic• http://www.fda.gov/cdrh/devadvice/http://www.fda.gov/cdrh/devadvice/

Division of Small Manufacturers, International, and Consumer Assistance (DSMICA)Division of Small Manufacturers, International, and Consumer Assistance (DSMICA)• Technical Assistance for the Medical Device IndustryTechnical Assistance for the Medical Device Industry• 800-638-2041 or 240-276-3150800-638-2041 or 240-276-3150• DSMICA@cdrh.fda.govDSMICA@cdrh.fda.gov

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Industry Assistance CDRH LearnIndustry Assistance CDRH LearnWhat is CDRH Learn?What is CDRH Learn?

• NewNew Online Training tool Online Training tool • Multi-Media Presentation Multi-Media Presentation • Available 24/7Available 24/7• Certificate generated per topic upon passing post-testsCertificate generated per topic upon passing post-tests• Suggest Future topicsSuggest Future topics

Examples of ModulesExamples of Modules• Overview of Regulatory Requirements: Medical Devices Overview of Regulatory Requirements: Medical Devices • Quality System Regulation 21 CFR 820 Basic IntroductionQuality System Regulation 21 CFR 820 Basic Introduction• Registration & Listing Registration & Listing (under development)(under development)

http://www.fda.gov/cdrh/cdrhlearn/http://www.fda.gov/cdrh/cdrhlearn/

Key FDA ContactsKey FDA Contacts Greg Holt,            FDA Field Officer in AlaskaGreg Holt,            FDA Field Officer in Alaska

Business: (907) 271-1246Business: (907) 271-1246 E-mail: E-mail: greg.holt@fda.hhs.govgreg.holt@fda.hhs.gov

Ernest Smith FDAErnest Smith FDABusiness: (240) 276-0115 ext 5Business: (240) 276-0115 ext 5

E-mail: E-mail: ernest.smith@fda.hhs.governest.smith@fda.hhs.gov                               Centers for Devices and Radiological Health, Consumer Safety OfficerCenters for Devices and Radiological Health, Consumer Safety Officer

Industry ResourcesIndustry Resources

Contact NADLContact NADL800/950-1150800/950-1150www.nadl.orgwww.nadl.org

www.fda.gov/cdrhwww.fda.gov/cdrh